CONTEXT: Physical activity is important for health, yet few studies have examined the effectiveness of physical activity patient counseling in primary care. OBJECTIVE: To compare the effects of 2 physical activity counseling interventions with current recommended care and with each other in a. primary care setting. DESIGN: The Activity Counseling Trial, a randomized controlled trial with recruitment in 1995 to 1997, with 24 months of follow-up. SETTING: Eleven primary care facilities affiliated with 3 US clinical research centers. PARTICIPANTS: Volunteer sample of 395 female and 479 male inactive primary care patients aged 35 to 75 years without clinical cardiovascular disease. INTERVENTIONS: Participants were randomly assigned to 1 of 3 groups: advice (n = 292), which included physician advice and written educational materials (recommended care); assistance (n = 293), which included all the components received by the advice group plus interactive mail and behavioral counseling at physician visits; or counseling (n = 289), which included the assistance and advice group components plus regular telephone counseling and behavioral classes. Main Outcome Measures Cardiorespiratory fitness, measured by maximal oxygen uptake (VO2max) and self-reported total physical activity, measured by a 7-day Physical Activity Recall, compared among the 3 groups and analyzed separately for men and women at 24 months. RESULTS: At 24 months, 91.4% of the sample had completed physical activity and 77.6% had completed cardiorespiratory fitness measurements. For women at 24 months, VO2max was significantly higher in the assistance group than in the advice group (mean difference 80.7 mL/min; 99.2% confidence interval (CI) 8.1 to 153.2 mL/min) and in the counseling group than in the advice group (mean difference 73.9 mL/min; 99.2% CI 0.9 to 147.0 mL/min), with no difference between the counseling and assistance groups and no significant differences in reported total physical activity. For men, there were no significant between-group differences in cardiorespiratory fitness or total physical activity. Conclusions Two patient counseling interventions differing in type and number of contacts were equally effective in women in improving cardiorespiratory fitness over 2 years compared with recommended care. In men, neither of the 2 counseling interventions was more effective than recommended care.

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